Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October through December 2021, 7458-7471 [2022-02677]

Download as PDF 7458 Federal Register / Vol. 87, No. 27 / Wednesday, February 9, 2022 / Notices (OMB control number: 0938–1249); Frequency: Annually; Affected Public: Public sector (Individuals and Households); Private sector (Business or other for-profits and Not-for-profit institutions); Number of Respondents: 314; Total Annual Responses: 314; Total Annual Hours: 384,014. For policy questions regarding this collection contact Nidhi Singh Shah at 301–492– 5110. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: February 4, 2022. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. AGENCY: [FR Doc. 2022–02738 Filed 2–8–22; 8:45 am] BILLING CODE 4120–01–P [CMS–9133–N] It is possible that an interested party may need specific information and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing contact persons to answer general questions concerning each of the addenda published in this notice. FOR FURTHER INFORMATION CONTACT: Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—October through December 2021 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other SUMMARY: Addenda Contact I CMS Manual Instructions .............................. II Regulation Documents Published in the Federal Register. III CMS Rulings ............................................... IV Medicare National Coverage Determinations. V FDA-Approved Category B IDEs ................. VI Collections of Information ........................... VII Medicare –Approved Carotid Stent Facilities. VIII American College of Cardiology-National Cardiovascular Data Registry Sites. IX Medicare’s Active Coverage-Related Guidance Documents. X One-time Notices Regarding National Coverage Provisions. XI National Oncologic Positron Emission Tomography Registry Sites. XII Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities. XIII Medicare-Approved Lung Volume Reduction Surgery Facilities. XIV Medicare-Approved Bariatric Surgery Facilities. XV Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials. All Other Information ......................................... Ismael Torres ................................................... Terri Plumb ....................................................... (410) 786–1864 (410) 786–4481 Tiffany Lafferty .................................................. Wanda Belle, MPA ........................................... (410)786–7548 (410) 786–7491 John Manlove ................................................... William Parham ................................................ Sarah Fulton, MHS ........................................... (410) 786–6877 (410) 786–4669 (410) 786–2749 Sarah Fulton, MHS ........................................... (410) 786–2749 JoAnna Baldwin, MS ........................................ (410) 786–7205 JoAnna Baldwin, MS ........................................ (410) 786–7205 David Dolan, MBA ............................................ (410) 786–3365 David Dolan, MBA ............................................ (410) 786–3365 Sarah Fulton, MHS ........................................... (410) 786–2749 Sarah Fulton, MHS ........................................... (410) 786–2749 David Dolan, MBA ............................................ (410) 786–3365 Annette Brewer ................................................. (410) 786–6580 SUPPLEMENTARY INFORMATION: Association of Insurance Commissioners (NAIC), health insurers, and other stakeholders. To implement the various statutes on which the programs are based, we issue regulations under the authority granted to the Secretary of the Department of Health and Human Services under sections 1102, 1871, 1902, and related provisions of the Social Security Act (the Act) and Public Health Service Act. We also issue various manuals, memoranda, and statements necessary to administer and oversee the programs efficiently. Section 1871(c) of the Act requires that we publish a list of all Medicare manual instructions, interpretive rules, statements of policy, and guidelines of general applicability not issued as regulations at least every 3 months in the Federal Register. I. Background lotter on DSK11XQN23PROD with NOTICES1 Centers for Medicare & Medicaid Services Federal Register notices that were published from July through September 2021, relating to the Medicare and Medicaid programs and other programs administered by CMS. The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs and coordination and oversight of private health insurance. Administration and oversight of these programs involves the following: (1) Furnishing information to Medicare and Medicaid beneficiaries, health care providers, and the public; and (2) maintaining effective communications with CMS regional offices, state governments, state Medicaid agencies, state survey agencies, various providers of health care, all Medicare contractors that process claims and pay bills, National VerDate Sep<11>2014 17:29 Feb 08, 2022 Jkt 256001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 Phone No. II. Format for the Quarterly Issuance Notices This quarterly notice provides only the specific updates that have occurred in the 3-month period along with a hyperlink to the full listing that is available on the CMS website or the appropriate data registries that are used as our resources. This is the most current up-to-date information and will be available earlier than we publish our quarterly notice. We believe the website list provides more timely access for beneficiaries, providers, and suppliers. We also believe the website offers a more convenient tool for the public to find the full list of qualified providers E:\FR\FM\09FEN1.SGM 09FEN1 Federal Register / Vol. 87, No. 27 / Wednesday, February 9, 2022 / Notices lotter on DSK11XQN23PROD with NOTICES1 for these specific services and offers more flexibility and ‘‘real time’’ accessibility. In addition, many of the websites have listservs; that is, the public can subscribe and receive immediate notification of any updates to the website. These listservs avoid the need to check the website, as notification of updates is automatic and sent to the subscriber as they occur. If assessing a website proves to be difficult, the contact person listed can provide information. VerDate Sep<11>2014 17:29 Feb 08, 2022 Jkt 256001 III. How To Use the Notice This notice is organized into 15 addenda so that a reader may access the subjects published during the quarter covered by the notice to determine whether any are of particular interest. We expect this notice to be used in concert with previously published notices. Those unfamiliar with a description of our Medicare manuals should view the manuals at https:// www.cms.gov/manuals. The Director of the Office of Strategic Operations and Regulatory Affairs of the PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 7459 Centers for Medicare & Medicaid Services (CMS), Kathleen Cantwell, having reviewed and approved this document, authorizes Trenesha FultzMimms, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. Trenesha Fultz-Mimms, Federal Register Liaison, Department of Health and Human Services. BILLING CODE 4120–01–C E:\FR\FM\09FEN1.SGM 09FEN1 lotter on DSK11XQN23PROD with NOTICES1 Jkt 256001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4725 E:\FR\FM\09FEN1.SGM 09FEN1 How to Obtain Manuals The Internet-only Manuals (IOMs) are a replica of the Agency's official record copy. Paper-based manuals are CMS manuals that were officially released in hardcopy. The majority of these manuals were transferred into the Internet-only manual (IOM) or retired. Pub 15-1, Pub 15-2 and Pub 45 are exceptions to this rule and are still active paper-based manuals. The remaining paper-based manuals are for reference purposes only. If you notice policy contained in the paper-based manuals that was not transferred to the IOM, send a message via the CMS Feedback tool. Those wishing to subscribe to old versions of CMS manuals should contact the National Technical Information Service, Department of Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone (703-605-6050). You can download copies of the listed material free of charge at: https://cms.gov/manuals. Fee-For Service Transmittal Numbers Please Note: Beginning Friday, March 20, 2020, there will be the following change regarding the Advance Notice of Instructions due to a CMS internal process change. Fee-For Service Transmittal Numbers will no longer be determined by Publication The Transmittal numbers will be issued by a single numerical sequence beginning with Transmittal Number 10000. For the purposes of this quarterly notice, we list only the specific updates to the list of manual instructions that have occurred in the 3-month period. This information is available on our website at www.crns.gov/Manuals. Transmittal Number 11136 Manual/Subject/Publication Number Update to Medicare Deductible, Coinsurance and Premium Rates for Calendar Year (CY) 2022 None How to Review Transmittals or Program Memoranda Those wishing to review transmittals and progrnm memoranda can access this information at a local Federal Depository Library (FDL). Under the FDL program, government publications are sent to approximately 1,400 designated libraries throughout the United States. Some FDLs may have arrangements to transfer material to a local library not designated as an FDL. Contact any library to locate the nearest FDL. This information is available at https://www.gpo.gov/librnries/ In addition, individuals may contact regional depository librnries that receive and retain at least one copy of most federal government 11119 National Coverage Determination (NCU) 270.3 Hlood-Uerived Products for Chronic, Non-Healing Wounds 12376 Revisions to Chapters 13, 18 And 32 To Update Coding Coverage for PET Scans for Dementia and Neurodegenerative Diseases Screening Pap Smears: Diagnoses Codes MSN Messages Remittance Advice Codes Screening Pelvic Examinations From January 1, 1998, Through June 30 2001 Diagnoses Codes MSN Messae:es Federal Register / Vol. 87, No. 27 / Wednesday, February 9, 2022 / Notices 17:29 Feb 08, 2022 Addendum I: Medicare and Medicaid Manual Instructions (October through December 2021) The CMS Manual System is used by CMS progrnm components, partners, providers, contractors, Medicare Advantage organizations, and State Survey Agencies to administer CMS progrnms. It offers day-to-day operating instructions, policies, and procedures based on statutes and regulations, guidelines, models, and directives. In 2003, we transformed the CMS Program Manuals into a web user-friendly presentation and renamed it the CMS Online Manual System. publications, either in printed or microfilm form, for use by the general public. These librnries provide reference services and interlibrary loans; however, they are not sales outlets. Individuals may obtain information about the location of the nearest regional depository librnry from any library. CMS publication and transmittal numbers are shown in the listing entitled Medicare and Medicaid Manual Instructions. To help FDLs locate the materials, use the CMS publication and transmittal numbers. For example, to find the manual for Update to Medicare Deductible, Coinsurance and Premium Rates for Calendar Year (CY) 2022, use (CMS-Pub. 100-01) Transmittal No. 11136. Addendum I lists a unique CMS transmittal number for each instruction in our manuals or progrnm memoranda and its subject number. A transmittal may consist of a single or multiple instruction(s). Often, it is necessary to use information in a transmittal in conjunction with information currently in the manual. 7460 VerDate Sep<11>2014 EN09FE22.000</GPH> Publication Dates for the Previous Four Quarterly Notices We publish this notice at the end of each quarter reflecting information released by CMS during the previous quarter. The publication dates of the previous four Quarterly Listing of Progrnm Issuances notices are: March 17, 2021 (86 FR 14629), May 3, 2021 (86 FR 23373), August 17, 2021 (86 FR 45986) and November 18, 2021 (86 FR 64492). We are providing only the specific updates that have occurred in the 3-month period along with a hyperlink to the website to access this information and a contact person for questions or additional information lotter on DSK11XQN23PROD with NOTICES1 VerDate Sep<11>2014 Jkt 256001 11022 PO 00000 11023 Frm 00040 11024 11035 11036 11937 Fmt 4703 11038 11039 Sfmt 4725 11042 E:\FR\FM\09FEN1.SGM 11043 11044 11046 11048 09FEN1 11049 11052 11057 11059 11061 11062 7461 11063 Carotid Artery Stenting fCAS] for Post-Approval Studies 510k Post-Approval Extension Studies using 510k-Cleared Embolic Protection Devices during Carotid Artery Stenting [CAS] Procedures Intracranial Percutaneous Transluminal Angioplasty [PTA] With Stenting Billing Requirements Payment Requirements Hospital Billing Instructions Practitioner Billing Instructions Claims Processing System Editing Claims Processing Requirements for OPT with Verteporf"m Services on Professional Claims and Outpatient Facility Claims Claims Processing Requirements for OPT with V crtcporf"m Services on Inpatient Facility Claims Coding and Claims Processing for MTW A Quarterly Update for the Durable Medical Equipment (DME), Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP) Januarv 2022 Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivitv of Instruction Instructions for Downloading the Medicare ZIP Code File for Januarv 2022 Revisions to Chapters 3, 18, and 32 to Update Coding Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivitv of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivitv of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) Updates for Fiscal Year (FY) 2022 Annual Update Cost-of-Living Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Calendar Year (CY) 2022 Participation Enrollment and Medicare Participating Phvsicians and Suooliers Directorv (MF.DP ARD) Procedures Ambulance Inflation Factor (AlF) for Calendar Year (CY) 2022 and Productivilv Adiustmenl Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidcntialitv of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction 2022 Annual Update of Healthcare Common Procedure Coding System (HCPCS) Codes for Skilled Nursing Facility (SNF) Consolidated Billing (CB)Update Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivitv of Instruction April 2022 Update to the Java Medicare Code Editor (MCE) for :'-l"ew Edit 20Unspecified Code Edit Medicare Code Editor (MCE) Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Federal Register / Vol. 87, No. 27 / Wednesday, February 9, 2022 / Notices 17:29 Feb 08, 2022 EN09FE22.001</GPH> Diagnosis Coding Remittance Advice Notices Counseling to Prevent Tobacco Use Healthcare Common Procedure Coding System [HCPCS] and Diagnosis Coding A/B MACs [BJ Billing Requirements A/B MAC [A] and [HHH] Billing Requirements Claims Adjustment Reason Codes [CARCs], Remittance Advice Remark Codes [RARCs ], Group Codes, and Medicare Summary Notices [MSNs] Common Working File [CWF] Diagnosis Code Reporting Billing Requirements Claim Adjustment Reason Codes [CARCs ], Remittance Advice Remark Codes [RARCs ], Group Codes, and Medicare Summary Notice [MSN] Messages Common Working File [CWF] Edits Ambulatory Blood Pressure Monitoring [ABPM] Billing Requirements Billing Requirements for HBO Therapy for the Treatment of Diabetic Wounds of the Lower Extremities Bill Types Allowable Covered Diagnosis Codes Allowable Covered Procedure Codes Healthcare Common Procedure Coding System [HCPCS] Coverage for PET Scans for Dementia and Neurodegenerative Diseases Special Billing and Payment Requirements for A/B MACs [A] A/B MACs [BJ Billing Requirements Ail:l MAC lAJ and lHHHJ l:lilling Requirements Claims Adjustment Reason Codes [CARCs], Remittance Advice Remark Codes [RARCs ], Group Codes, and Medicare Summary Notices [MSNs] Common Working File [CWF] Diagnosis Code Reporting Billing Requirements Claim Adjustment Reason Codes [CARCs], Remittance Advice Remark Codes [RARCs ], Group Codes, and Medicare Summary Notice [MSN] Messages Common Working File [CWF] Edits Ambulatory Blood Pressure Monitoring [ABPM] Billing Requirements Billing Requirements for HBO Therapy for the Treatment of Diabetic Wounds of the Lower Extremities Bill Types Allowable Covered Diagnosis Codes Allowable Covered Procedure Codes Healthcare Common Procedure Coding System [HCPCS] Coverage for PET Scans for Dementia and Neurodegenerative Diseases Special Billing and Payment Requirements for A/B MACs [A] Diagnosis Codes Editing Instructions for AIB MACs [A Correct Place of Service [POS] Code for PR Services on Professional Claims Requirements for PR Services on Institutional Claims Edits for PR Services Exceeding 72 Sessions ICD Procedure Codes for Bariatric Surgery for Treatment of Co- Morbid Conditions Related to Morbid Obesity [A/MACs only !CD Diagnosis Codes for Bariatric Surgery ICD Diagnosis Codes for BMI □ 35 !CD Codes for Type II Diabetes Mellitus Complication Claims Guidance for Payment Medicare Summarv Notices [MSNs] and Claim Adjustment Reason Codes lotter on DSK11XQN23PROD with NOTICES1 11072 11074 11077 Jkt 256001 11079 11080 PO 00000 11082 11084 Frm 00041 11085 11089 Fmt 4703 11090 11092 Sfmt 4725 11093 11095 E:\FR\FM\09FEN1.SGM 11107 11109 11111 11113 09FEN1 11114 11115 11116 11117 11118 11119 EN09FE22.002</GPH> 11121 11122 11122 11129 11130 11131 11138 11140 11146 11147 11149 11150 11069 11070 11073 Chronic, Non-Healing Wounds Autologous Platelet-Rich Plasma (PRP) for Chronic Non-Healing Wounds Policy Healthcare Common Procedure Coding System (HCPCS) Codes, Diagnosis Coding and Frequency Requirements Types of Bill (TOB) Payment Method Place of Service (POS) for Professional Claims Combined Common Edits/Enhancements Modules (CCEM) Code Set Codate Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivity of Instruction Reduced Payment for Physical Therapy and Occupational Therapy Services Furnished In Whole or In Part by a Physical Therapist Assistant (PTA) or Occupational Therapy Assistant (OTA) Discipline Specific Outpatient Rehabilitation Modifiers - All Claims Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivity of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Ouartcrly Update to Home Health (HH) Grouper Update to the Internet Only Manual (!OM) Publication 100-04, Chapters 3 and 17 Summary of Policies in the Calendar Year (CY) 2022 Medicare Physician Fee Schedule (MPFS) Final Rule, Telehealth Originating Site Facility Fee Payment Amount and Telehealth Services List, CT Modifier Reduction List, and Preventive Services List Implement Operating Rules - Phase III Electronic Remittance Advice (ERA) Electronic Funds Transfer (EFT): Committee on Operating Rules for Information Exchange (CORE) 360 Uniform Use of Claim Adjustment Reason Codes (CARC), Remittance Advice Remark Codes (RARC) and Claim Adjustment Group Code (CAGC) Rule - Update from Council for Affordable Ouality Healthcare (CAOH) CORE January 2022 Integrated Outpatient Code Editor (1/OCE) Specifications Version 23.0 January 2022 Update of the Hospital Outpatient Prospective Payment System (OPPS) General Coding and Dilling Instructions and Explanations Explanations of Terms Complete List of Device Pass-through Category Codes Explanations of Certain Terms/Definitions Related to Device Pass-Through Category Codes Billing for Allogeneic Stem Cell Transplants ECRS Updates to the Prescription Drug Assistance Request (PDAR) Fields; Medicare Secondary Payer Future Date Fields; Electronic File Transfer ~faming Convention; Updated ICD-10 Diagnosis Codes for NoFault Plan Insurance Type D and the Addition of Reason Code 94 Attachment 1 - ECRS Web User Guide, Software Version 6.7 Attachment 2 - ECRS Web Ouick Reference Card Version 2021/1 October Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Federal Register / Vol. 87, No. 27 / Wednesday, February 9, 2022 / Notices 17:29 Feb 08, 2022 11075 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Calendar Year (CY) 2022 Participation Enrollment and Medicare Participating Physicians and Suppliers Directory (MEDPARD) Procedures Revision to Chapter 3 to Update Instructions for Handling Inpatient Rehabilitation Facility (!RF) Claims Shared Systems and CWF Edit~ Actions When a Claim Does Not Match the Jnpatient Rehabilitation Facility-Patient Assessment Instrument ORF-P Al) Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Issued to a specific audience, not posted to Internet/Intranet dne to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Coniidenlialily of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction File Conversions Related to the Spanish Translation of the Healthcare Common Procedure Coding Svstem (HCPCS) Descriptions Claims Processing Instructions for the New Pneumococcal 20-valent Coniugate Vaccine Code 90677 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Implementation of the GV Modifier for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) for Billing Hospice Attending Phvsician Services 2022 Annual Update of Per-Beneficiarv Threshold Amounts Skilled Nursing facility (SNF) Claims Processing Updates Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easv Print (MREP) and PC Print Update Update to the Internet Only Manual (!OM) Publication (Pub.) 100-04, Chapter 3, Sections 90.1.2, 90.3, 90.3.1, and Addendum A Provider Specific File Provider Specific File Billing for Kidney Transplant and Acquisition Services Stem Cell Transplantation Allogeneic for Stem Cell Transplantation Instructions for Retrieving the January 2022 Medicare Physician Fee Schedule Database (MPFSDB) Files Through the CMS Mainframe Telecommunications Svstem Summary of Policies in the Calendar Year (CY) 2022 Medicare Physician Fee Schedule (MPFS) Final Rule, Telehealth Originating Site Facility Fee Payment Amount and Telehealth Services List, CT Modifier Reduction List, and Preventive Services List April 2022 Healthcare Common Procedure Coding System (HCPCS) Ouarterlv Update Reminder Shared System Support Hours for Application Programming Interfaces (APis) 2022 Annual Update to the Theranv Code List National Coverage Determination (NCD) 270.3 Blood-Derived Products for 7462 VerDate Sep<11>2014 11066 lotter on DSK11XQN23PROD with NOTICES1 VerDate Sep<11>2014 11051 11097 11112 11133 Jkt 256001 None 11014 PO 00000 11020 Frm 00042 Fmt 4703 Sfmt 4725 E:\FR\FM\09FEN1.SGM 09FEN1 11031 EN09FE22.003</GPH> 11040 11050 11064 11065 11086 11087 11088 11091 11094 11125 11126 11135 11139 11142 7463 11032 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Restructuring of Section 10.4 in Chapter 10 of Publication (Pub.) 100-08 10.2.3/Individual Practitioners Who Enroll Via the Form CMS-855I Medicare Enrollment - Contractor Processing Duties and Related Polic General Processing Functions Overview of the Process Receipt of Application Review of Application Initial Steps of Review of Application Data Verification Requesting Missing/Clarifying Data/Documentation (Development) Receiving Missing/Clarifying Data/Documentation (Response to Development Provider/Supplier Fails to Submit Requested Data/Documentation Application Disposition Approval Retums Rejections Denial Denials - General Principles Denial Reasons Additional Denial Policies Voluntary and Involuntary Terminations Changes of Information Revalidations Revalidation Solicitations Non-Responses to Revalidation and Extension Requests Receipt and Processing of Revalidation Applications Reactivations Revocations Revocations - Background and General Requirements Revocation Effective Dates Revocation Reasons Reenrollment Bar Additional Revocation Policies Deactivations Deactivation Rebuttals Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Updates to Chapters 1, 3, 4, 5, 8 and 9 of Publication (Pub.) 100-08 Quality of Care Issues and Potential Fraud Issues Provider Self Audits Signature Requirements Introduction Definitions Medicare Program Integrity Program Integrity Contractors Unified Program Integrity Contractor Investigations Medicare Drug Integrity Contractor Organizational Requirements Training for Law Enforcement Organizations Liability of Program Integrity Contractor Employees Anti-Fraud Training Training for Law Enforcement Organizations Procedural Requirements Maintain Controlled Filing System and Documentation Revisions to Certified Provider/Supplier Model Letters and Instructions for Processing Initial Skilled Nursing Facility (SNF) Enrollment Applications Issued lo a specific audience, not posted lo Internet/Intranet due lo Confidentiality of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality oflnstructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentialitv of Instructions Issued lo a specific audience, not posted lo Internet/Intranet due lo Confidentiality of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentialitv oflnstructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Update to Enrollment Processing Requirements for Certified Provider/Supplier Change of Ownership (CHOW) and Change of Information (COi) Application Issued to a specific audience, not posted to Internet/Intranet due to Confidenlialitv oflnstructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentialitv of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentialitv of Instructions Incorporation of Recent Provider Enrollment Regulatory Changes into Chapter 10 of CMS Publication (Pub.) 100-08 Definitions Federally Qualified Health Centers (FQHCs) Home Health Agencies (HHAs) Independent Diagnostic Testing Facilities (IDTFs Physician Assistants Retums Rejections Denial Reasons Additional Denial Policies Reactivations Revocation Reasons Reenrollment Dar Federal Register / Vol. 87, No. 27 / Wednesday, February 9, 2022 / Notices 17:29 Feb 08, 2022 11124 Notice of New Interest Rate for Medicare Overpayments and Underpayments -1st Otr Notification for FY 2022 The Fiscal Intermediary Shared System (FISS) Submission of Copybook Files to the Provider and Statistical Reimbursement (PS&R) Svstem Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Updates to Medicare Financial ~1anagement Manual Chapter 3, Section 140.1 Bankruptcv Forms Fiscal Year 2022 Updates for the CMS Internet Only Manual (IOM) Publication (Pub.) 100-06, Medicare Financial Management Manual, Chapter 7 - Intemal Control Reauirements lotter on DSK11XQN23PROD with NOTICES1 11127 11068 11076 11078 Jkt 256001 11083 None PO 00000 Frm 00043 None 11096 None 11098 11100 11103 None None Fmt 4703 11104 11110 None 11123 Sfmt 4725 11030 11053 E:\FR\FM\09FEN1.SGM 11067 11071 11108 11128 11143 09FEN1 11145 11010 11025 11033 11047 11054 EN09FE22.004</GPH> The Supplemental Security Income (SSI)/Medicare Beneficiary Data for Fiscal Year (FY) 2019 for Inpatient Prospective Payment System (IPPS) Hospitals, Inpatient Rehabilitation Facilities (IRFs), and Long-Term Care Hospitals (LTCHs) 11060 Issued to a specific audience, not posted to Intecnet/Intranet due to Sensitivity of Instructions Issued to a specific audience, not posted to Intecnet/Intranet due to Sensitivity oflnstructi ans Intravenous Immune Globulin (IVIG) Demonstration Update for a New Drug Code J1554 ASCENIV Modifications/Improvements to Value-Based Insurance Design (VBID) Model - Implementation Managing Clinician PPA and KCF PEA Implementation ESRD Treatment Choices (ETC) Model Performance Payment Adjustment (PPA) - Facility Component (Implementation CR) Intravenous Immune Globulin (IVIG) Demonstration: Payment Update for 2022 Issued to a specific audience, not posted to Intecnet/Intranet due to Sensitivity oflnstructi ons Mobile Personal Identity Verification (PIV) Station Installation International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs)--January 2022 Implementation of the Award for the Jurisdiction L (J-L) Part A and Part B Medicare Administrative Contractor (JL AIB MAC) Correct Processing of Home Health Claims if the Request for Anticipated Payment (RAP) or cl<otice of Admission (NOA) Was More Than 30 Days Late and Correct Identification Critical Access Hospital Sub-t:nit Discharges as Institutional Periods of Care Electronic Funds Transfer (EFT) Information from Provider Enrollment Chain and Ownership System (PECOS) to ViPS Medicare System (VMS): 11132 11134 11141 11144 11155 11156 Implementation CR National Coverage Determination (NCD) 90.2, cl<ext Generation Sequencing (NGS) Skilled cl<ursing Facility (SNF) Claims Processing Update to Fiscal Year End (FYE) Edits International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs) -- April 2022 (CR 1 of2) User Change Request (UCR): Fiscal Intermediary Shared System (FISS) Workload Reports to Capture Optical Character Reader (OCR) and Paper Claim Counts Correctly User Change Request (UCR) - Fiscal Intermediary Shared System (FISS) Implcmcnt New Search Functionality for Reason Codes, Expert Claims Processine: Svstem ffiCPS) and Medical Policv Parameters (MPP) International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs) -- April 2022 (CR 2 of2 for April 2022) Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instructions MAC Customer Experience (MCE) Provider Enrolhnent Survey Link User CR: Multi-Carrier System (MCS) - Beneficiarv Age Data Element Clarifying Instructions for Billing and Processing and Payment of Claims Based on Locality of the Home Infusion Therapy (HIT) Service Visit User CR: Multi-Carrier Svstem (MCS) - PSUP Ouerv Svstem Lookuo Phase two: Undeliverable Medicare Summary Notices (UMSNs)Beneficiarv Do Not Forward Process Send Electronic Funds Transfer (EFT) Information from Provider Enrolhnent Chain and Ownership System (PECOS) to Fiscal Intermediary Shared System (FISS) - Implementation CR, Consolidation of January 2022 and April 2022 Releases. Medicare Diabetes Prevention Program (MDPP) Service Period Change from 2 Years to I Year Medicare Administrative Contractor (MAC) Educational Requirements for the Expansion of the Repetitive, Scheduled Non-Emergent Ambulance Transport (RSNAT) Prior Authorization (PA) Model User Change Request (UCR) - Fiscal Intermediary Shared System (FISS) Implement New Search Functionality for Reason Codes, Expert Claims Processine: Svstem (ECPS) and Medical Policv Parameters fMPP) Implementation of Medicare Administrative Contractor (MAC) Appeals Upload Process Changes for the Recovery Audit Contractor (RAC) Data Warehouse (RACDW) and Addition of Disposition Category "U" to RACDW Anneals Layout File Correct Processing of Home Health Claims if the Request for Anticipated Payment (RAP) or Notice of Admission (NOA) Was More Than 30 Days Late and Correct Identification Critical Access Hospital Sub-Unit Discharges as Institutional Periods of Care Addition of the QW modifier to Healthcare Common Procedure Coding System (HCPCS) Code 86328 None None None Federal Register / Vol. 87, No. 27 / Wednesday, February 9, 2022 / Notices 17:29 Feb 08, 2022 11154 11055 7464 VerDate Sep<11>2014 11153 Deactivations Deactivation Rebuttals Establishing Effective Dates Opting-Out of Medicare Application Fees Issued to a specific audience, not posted to Intecnet/Intranet due to Confidentialitv of Instructions Incorporation of Rcccnt Provider Enrollment Regulatory Changes into Chanter IO of CMS Publication (Pub.) 100-08 lotter on DSK11XQN23PROD with NOTICES1 VerDate Sep<11>2014 Jkt 256001 PO 00000 Frm 00044 Fmt 4703 For questions or additional information, contact Terri Plumb (410-786-4481). Sfmt 4725 E:\FR\FM\09FEN1.SGM 09FEN1 Addendum m: CMS Rulings (October through December 2021) CMS Rulings are decisions of the Administrator that serve as precedent final opinions and orders and statements of policy and interpretation. They provide clarification and interpretation of complex or ambiguous provisions of the law or regulations relating to Medicare, Medicaid, Utilization and Quality Control Peer Review, private health insurance, and related matters. The rulings can be accessed at htt;p://www.crns.gov/Regulationsand-Guidance/Guidance/Rulings. For questions or additional information, contact Tiffany Lafferty (410-786-7548). Title Transvenous Pulmonary Embolcctomv (TPE) 240.6 National Coverage Determination (NCD) 220.6.19, Positron Emission Tomography NaF-18 (NaF18 PET) to Identify Bone Metastasis of CancerManual Update Onlv NCDM Section Transmittal Number Issue Date Effective Date NCD240.6 ID9875 12/16/2021 10/28/2021 NCD 220.6.19 11158 12/17/2021 01/19/2021 Addendum V: FDA-Approved Category B Tnvestigational Device Exemptions (IDEs) (October through December 2021) (Inclusion of this addenda is under discussion internally.) Addendum VT: Approval Numbers for Collections of Information (October through December 2021) All approval numbers are available to the public at Reginfo.gov. Under the review process, approved information collection requests are assigned 0MB control numbers. A single control number may apply to several related information collections. This information is available at www.reginfo.gov/public/do/PRAMain. For questions or additional information, contact William Parham (410-786-4669). Addendum VII: Medicare-Approved Carotid Stent Facilities (October through December 2021) Addendum VII includes listings of Medicare-approved carotid stent facilities. All facilities listed meet CMS standards for performing carotid artery stenting for high risk patients. On March 17, 2005, we issued our decision memorandum on carotid artery stcnting. W c determined that carotid artery stenting with embolic protection is reasonable and necessary only if performed in facilities that have been determined to be competent in performing the evaluation, procedure, and follow-up necessary to ensure optimal patient outcomes. We have created a list of minimum standards for 7465 Addendum IV: Medicare National Coverage Determinations (October through December 2021) Addendum IV includes completed national coverage determinations (NCDs), or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions are identified by the section of the NCD Manual (NCDM) in which the decision appears, the title, the date the publication was issued, and the effective date of the decision. An NCD is a determination by the Secretary for whether or not a particular item or service is covered nationally under the Medicare Program (title XVIII of the Act), but does not include a determination of the code, if any, that is assigned to a particular covered item or service, or payment determination for a particular covered item or service. The entries below include information concerning completed decisions, as well as sections on program and decision memoranda, which also announce decisions or, in some cases, explain why it was not appropriate to issue an NCD. Information on completed decisions as well as pending decisions has also been posted on the CMS website. For the purposes of this quarterly notice, we are providing only the specific updates to national coverage determinations (NCDs), or reconsiderations of completed NCDs published in the 3-month period. This information is available at www.crns.gov/medicare-coverage-database/. For questions or additional information, contact Wanda Belle, MPA (410-786-7491). Federal Register / Vol. 87, No. 27 / Wednesday, February 9, 2022 / Notices 17:29 Feb 08, 2022 EN09FE22.005</GPH> Addendum II: Regulation Documents Published in the Federal Register (October through December 2021) Regulations and Notices Regulations and notices are published in the daily Federal Register. To purchase individual copies or subscribe to the Federal Register, contact GPO at www.gpo.gov/fdsys. When ordering individual copies, it is necessary to cite either the date of publication or the volume number and page number. The Federal Register is available as an online database through GPO Access. The online database is updated by 6 a.m. each day the Federal Register is published. The database includes both text and graphics from Volume 59, Number 1 (January 2, 1994) through the present date and can be accessed at https://www.gpoaccess.gov/fr/. The following website https://www.archives.gov/federal-register/ provides information on how to access electronic editions, printed editions, and reference copies. This information is available on our website at: https://www.cms.gov/fi1es/document/regs4q2lqpu.pdf lotter on DSK11XQN23PROD with NOTICES1 Jkt 256001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4725 Provider Number Date Approved State Berkeley Medical Center 2500 Hospital Drive Martinsburg, WV 25401 CGH Medical Center 100 E Lefevre Road Sterling, IL 61081 Lee's Summit Medical Center 2100 SE Blue Parkway Lee's Summit, MO 64043 McKenzie Willamette Medical Center 1460 G Street Provider Springfield, OR 97477 Raleigh General Hospital 1710 Harper Road Becklev, WV 25801 Faith Regional Health Services 2700 W. Norfolk Avenue Norfolk, NE 68701 510008 10/12/2021 WV E:\FR\FM\09FEN1.SGM 09FEN1 FROM: St. Joseph Hospital TO: PeaceHealth St. Joseph Medical Center 2901 Squalicum Parkway Bellingham WA 98264 FROM: Sacred Heart Medical Center at RiverBend TO: PeaceHealth Sacred Heart Riverbend Medical Center 3311 RiverBend Drive Snringfield OR 97477 FROM: Western Baptist Hospital TO: Baptist Health Paducah 2501 Kentucky Avenue Paducah, KY 42003 FROM: St. John Hospital and Medical Center TO: Ascension St. John Hospital 22101 Moross Road Detroit MI 48236 FROM: Huntsville Health System Marshall, LLC 140043 10/12/2021 IL 260190 09/27/2021 MO 380020 10/15/2021 OR 510070 12/07/2021 WV 280125 12/14/2021 NE 500030 09/28/2005 WA 380102 02/19/2009 OR 180104 05/05/2005 KY 230165 04/27/2005 MI 010005 09/21/2021 AL TO: HH Health System - Marshall, LLC 2505 431 Highway North Boaz AL 35957 FROM: North Hills TO: Medical City North Hills 4401 Booth Calloway Road North Richland Hills, TX 76180 FROM: Carillon Roanoke Memorial Hospital TO: Roanoke Memorial Hospital 1906 Belleview Avenue Roanoke, VA 24014 Provider Number Date Approved State 450087 01/24/2006 TX 490024 09/06/2005 VA Addendum Vlll: American College of Cardiology's National Cardiovascular Data Registry Sites (October through December 2021) The initial data collection requirement through the American College of Cardiology's National Cardiovascular Data Registry (ACCNCDR) has served to develop and improve the evidence base for the use of I CDs in certain Medicare beneficiaries. The data collection requirement ended with the posting of the fmal decision memo for Implantable CardiovertcrDefibrillators on February 15, 2018. For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Addendum IX: Active CMS Coverage-Related Guidance Documents (October through December 2021) CMS issued a guidance document on November 20, 2014 titled "Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development Document". Although CMS has several policy vehicles relating to evidence development activities including the investigational device exemption (IDE), the clinical trial policy, national coverage determinations and local coverage determinations, this guidance document is principally intended to help the public understand CMS' s implementation of coverage with evidence development (CED) through the national coverage determination process. The document is available at https://www.cms.gov/medieare-coverage-database/details/medicarecoverage-document-details.aspx?MCD1d=27. There are no additional Active CMS Coverage-Related Guidance Documents for the 3-month period. For questions or additional information, contact JoAnna Baldwin, MS (410-786-7205). AddendumX: List of Special One-Time Notices Regarding National Coverage Provisions (October through December 2021) Federal Register / Vol. 87, No. 27 / Wednesday, February 9, 2022 / Notices 17:29 Feb 08, 2022 Facility Facility 7466 VerDate Sep<11>2014 EN09FE22.006</GPH> facilities modeled in part on professional society statements on competency. All facilities must at least meet our standards in order to receive coverage for carotid artery stenting for high risk patients. For the purposes of this quarterly notice, we are providing only the specific updates that have occurred in the 3-month period. This information is available at: https://www.ems.gov/MedicareApprovedFacilitie/CASF/list.asp#TopOfPage For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). lotter on DSK11XQN23PROD with NOTICES1 VerDate Sep<11>2014 Addendum XI: National Oncologic PET Registry (NOPR) (October through December 2021) Jkt 256001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4725 Addendum XI includes a listing of National Oncologic Positron Emission Tomography Registry (NOPR) sites. We cover positron emission tomography (PET) scans for particular oncologic indications when they are performed in a facility that participates in the NOPR. In January 2005, we issued our decision memorandum on positron emission tomography (PET) scans, which stated that CMS would cover PET scans for particular oncologic indications, as long as they were performed in the context of a clinical study. We have since recognized the National Oncologic PET Registry as one of these clinical studies. Therefore, in order for a beneficiaty to receive a Medicare-covered PET scan, the beneficiary must receive the scan in a facility that participates in the registry. There were no additions, deletions, or editorial changes to the listing of National Oncologic Positron Emission Tomography Registry (NOPR) in the 3-month period. This information is available at https://www.cms.gov/MedicareApprovedFacilitie/NOPR/list.asp#TopOfPage. For questions or additional information, contact David Dolan, MBA (410786-3365). E:\FR\FM\09FEN1.SGM Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (October through December 2021) 09FEN1 Date of Recertification Facility Provider Number Date of Initial Certification State Summa Health 525 E. Market Street Akron, OH 44309 360020 11/16/2021 240057 11/16/2010 07/28/2021 MN 490059 12/15/2011 06/11/2021 VA 390223 10/05/2010 07/29/2021 PA 090001 09/12/2018 07/10/2021 DC OH Other information: DNV Certificate #: 10000496174-MSC-DNVUSA Previous Re-certification Dates: n/a Abbott Northwestern Hospital 800 East 28th Street Minneapolis, MN 55407 Other information: Joint Commission ID# 8149 Previous Re-certification Dates: lli16/2010; lli29/2012; lli18/2014; 12/06/2016; 2/13/2019 Bon Secours St. Mary's Hospital 5801 Bremo Road Riclunond, VA 23226 Joint Commission ID # 6387 Previous Re-certification Dates: 12i15/2011; 12/17/2013; 0li26/2016; 02/21/2018 Presbyterian Medical Center of theUPHS 51 North 39th Street Philadelphia, PA 19104 Other information: Joint Commission ID# 6145 Previous Re-certification Dates: 07i22/2010; 07/20/2012; 06i17/2014· 07/19/2016 The George Washington University Hospital 900 23rd Street. NW 7467 Addendum XII includes a listing of Medicare-approved facilities that receive coverage for ventricular assist devices (VADs) used as destination therapy. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy. On October 1, 2003, we issued our decision memorandum on VADs for the clinical indication of destination U1erapy. We detennined Uiat VADs used as destination therapy are reasonable and necessary only if performed in facilities that have been detennined to have the experience and infrastructure to ensure optimal patient outcomes. We established facility standards and an application process. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy. For the purposes of this quarterly notice, we are providing only the specific updates to the list of Medicare-approved facilities that meet our standards that have occurred in the 3-month period. This information is available at https://www.cms.gov/MedicareApprovedFacilitieNAD/list.asp#TopOfPage. For questions or additional information, contact David Dolan, MBA, (410-786-3365). Federal Register / Vol. 87, No. 27 / Wednesday, February 9, 2022 / Notices 17:29 Feb 08, 2022 EN09FE22.007</GPH> There were no special one-time notices regarding national coverage provisions published in the 3-month period. This information is available at https://www.cms.gov. For questions or additional information, contact Jo Anna Baldwin, MS (410-786 7205). lotter on DSK11XQN23PROD with NOTICES1 Provider Number Date of Initial Certification Date of Recertification State Washington, UC 20037 Jkt 256001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4725 E:\FR\FM\09FEN1.SGM 09FEN1 Date of Initial Certification Date of Recertification State Other information: Joint Commission ID # 6310 360180 12/03/2003 08/05/2021 OH 490032 04/08/2004 08/07/2021 VA 330285 10/29/2003 07/21/2021 NY 310073 10/16/2018 10/14/2021 NJ Joint Commission ID # 7029 Previous Re-certification Dates: 9/12/2018 Robert Wood Johnson University Hospital One Robert Wood Johnson Place New Brunswick, NJ 089032601 310038 07/22/2010 07/08/2021 NJ Previous Re-certification Dates: 04/14/2006; 11/18/2008; 10/22/2010; 10/23/2012; 10/03/2014; 10/28/2016; 10/24/2018 Cleveland Clinic 9500 Euclid Avenue NA-4 Cleveland, OH 44195 Joint Commission ID # 5969 Previous Re-certification Dates: 07/22/2010; 07/20/2012; 06/17/2014· 07/19/2016 TriStar Centennial Medical Center 2300 Patterson Street Nashville, TN 37203 Other information: Joint Commission ID# 7001 440161 12/12/2018 08/19/2021 1N Joint Commission ID # 7888 Previous Re-certification Dates: 12/12/2018 University of Maryland Medical Center 22 South Greene Street Baltimore, MD 21201-1595 210002 09/16/2008 07/03/2021 MD Previous Re-certification Dates: 10/25/2016;1 l/15/2018 Ohio State University Hospitals Other information: Joint Commission ID# 6381 Previous Re-certification Dates: 11/04/2008; 12/14/2010; 12/21/2012; 12/16/2014; 02/14/2017· 4/10/2019 Strong Memorial Hospital 601 Elmwood Avenue Rochester, NY 14642 Other information: Joint Commission ID # 6264 Previous Re-certification Dates: 09/16/2008; 08/25/2010; 08/15/2012; 08/19/2014; 09/20/2016; 9/26/2018 NorthShore University Health System 1301 Central Street, Suite 300 Evanston, IL 6020 I Previous Re-certification Dates: 10/28/2008; 11/23/201 O; 12/11/2012; 12/02/2014; 11/08/2016' 12/12/2018 Virginia Commonwealth University Health System 1250 East Marshall Street Riclunond, VA 23298-0510 Other information: Joint Commission ID# 5856 140010 10/25/2016 08/06/2021 IL 360085 11/12/2003 08/04/2021 OH Previous Re-certification Dates: 10/29/2003; 06/17/2008; 07/02/2010; 06/06/2012; 05/13/2014; 07/26/2016; 7/25/2018 Jersey Shore University Medical Center 1945 Route 33 Neptune City, NJ 07753 Federal Register / Vol. 87, No. 27 / Wednesday, February 9, 2022 / Notices 17:29 Feb 08, 2022 Provider Number 410 West Tenth Avenue, UN 168 Columbus, OH 43210 Other information: Joint Commission ID # 7343 EN09FE22.008</GPH> Facility 7468 VerDate Sep<11>2014 Facility lotter on DSK11XQN23PROD with NOTICES1 VerDate Sep<11>2014 Facility Provider Number Date of Initial Certification Date of Recertification State Advocate Christ Medical Center 4440 W. 95th Street Oak Lawn, IL 60453 140208 09/08/2015 10/21/2021 IL Jkt 256001 PO 00000 280003 03/05/2013 09/22/2021 NE Frm 00048 Fmt 4703 Sfmt 4725 E:\FR\FM\09FEN1.SGM 09FEN1 010033 12/09/2008 08/21/2021 AL Previous Re-certification Dates: 12/09/2008; 04/22i2011; 04/09/2013; 04/07i2015; 05/16/2017· 7/3/2019 Dignity Health 350 West Thomas Road Phoenix, AZ 85013 030024 05/08/2019 08/19/2021 AZ 220086 04/25/2017 11/04/2021 MA Previous Re-certification Dates: 5/8/2019 Fresno Community Hospital and Medical Center 2823 Fresno St. Fresno, CA 93721 050060 11/04/2014 08/11/2021 CA 230053 10/30/2008 07/29/2021 MI Other infonuation: Joint Commission ID# 9832 380091 09/13/2016 10/27/2021 OR Previous Re-certification Dates: 11/04/2014; 12/13i2016; 2/13i2019 FROM: Henry Ford Hospital TO: Henry Ford Health System 2799 West Grand Boulevard Detroit, MI 48202 Other infonuation: Joint Commission ID# 7485 330194 08/23/2012 10/27/2021 NY 7469 EN09FE22.009</GPH> Previous Re-certification Dates: 08/23/2012; 07/29i2014; 09/13/2016' 10/lli2018 University of Alabama at Birmingham 619 19th S. South Birmingham, AL 35249-1900 Other information: Joint Commission ID # 9494 Other information: Joint Commission ID# 4858 Previous Re-certification Dates: 09/13/2016; 09/19/2018 Maimonides Medical Center 4802 Tenth Avenue State Other infonuation: Joint Commission ID# 2814 Other information: Joint Commission ID# 5501 Previous Re-certification Dates: 04/25/2017; 05/22/2019 FROM: Kaiser Sunnyside Medical Center TO: Kaiser Foundation Hospital - Sunnyside 10180 SE Sunnyside Road Clackamas, OR 97015-9303 Date of Recertification Other infonuation: Joint Commission ID# 5734 Other infonuation: Joint Commission ID # 244330 Previous Re-certification Dates: 03/05/2013; 02/12/2015; 04/18/2017; 07/17/2019 Beth Israel Deaconess Medical Center 330 Brookline Avenue Boston, MA 02215 Date of Initial Certification Brooklyn, NY 11219-2916 Other information: DNV GL Certificate # 10000504196-MSC-DNVUSA Previous re-certification dates: 10/01/2018 Bryan Medical Center 1600 South 48th Street Lincoln, NE 68506 Provider Number Federal Register / Vol. 87, No. 27 / Wednesday, February 9, 2022 / Notices 17:29 Feb 08, 2022 Other information: DNV GL Certificate # 10000502976-MSC-DNVUSA Facility lotter on DSK11XQN23PROD with NOTICES1 Date of Recertification State Jkt 256001 PO 00000 Frm 00049 Previous Re-certification Dates: 12/02/2008; 01/19/201 l; 02/13/2013; 01/06/2015; 02/28/2017· 5/22/2019 Rochester General Hospital 1425 Portland Ave Rochester, NY 14621 220071 12/02/2008 10/14/2021 Fmt 4703 Sfmt 4725 E:\FR\FM\09FEN1.SGM 09FEN1 Previous Re-certification Dates: 01/16/2009; 06/30/2011; 06/04/2013; Date of Initial Certification Date of Recertification State 280013 01/20/2011 09/09/2021 NE 420018 03/06/2013 10/08/2021 SC Other information: Joint Co11l11lission ID# 186313 Previous Re-certification Dates: 01/20/2011; 01/29/2013; 02/24/2015; 02/14/2017; 4/17/2019 FROM: Palmetto Health TO: Prisma Health Richland 5 Richland Medical Park Drive Columbia, SC 29203 330125 10/29/2018 10/28/2021 NY Other information: Joint Co11l11lission ID # 6588 Previous Re-certification Dates: 03/06/2013; 04/21/2015; 06/06/2017; 6/28/2019 330393 03/02/2011 09/17/2021 NY 340030 10/31/2003 09/22/2021 NC Other information: Joint Co11l11lission ID# 5188 Previous Re-certification Dates: 01/30/2013; 01/15/2015; 03/14/2017; 05/08/2019 FROM: Duke University Hospital TO: Duke University Health System, Inc 2301 Erwin Road Dmham, NC 27710 Provider Number MA Other information: DNV certificate #: 10000504804-MSC-DNVUSA Previous Re-certification Dates: 10/29/2018 University Hospital (Stony Brook) Health Sciences Center Stony Brook Stony Brook, NY 11794-8503 Facility 05/05/2015; 06/13/2017; 08/21/2019 Nebraska Medical Center 4350 Dewey Avenue Omaha, NE 68198-7400 Other information: Joint Co11l11lission ID# 5513 Other information: Joint Co11l11lission ID # 6490 EN09FE22.010</GPH> Date of Initial Certification Addendum XIII: Lung Volume Reduction Surgery (LVRS) (October through December 2021) Addendum XIII includes a listing of Medicare-approved facilities that are eligible to receive coverage for lung volume reduction surgery. Until May 17, 2007, facilities that pruticipated in the National Emphysema Treatment Trial were also eligible to receive coverage. The following three types of facilities are eligible for reimbursement for Lung Volume Reduction Surgery (LVRS): • National Emphysema Treatment Trial (NETT) approved (Beginning 05/07/2007, these will no longer automatically qualify and can qualify only with the other programs); • Credentialed by the Joint Commission (formerly, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO)) under their Disease Specific Certification Program for L VRS; and • Medicare approved for lung transplants. Only the first two types are in the list There were no updates to the listing of facilities for lung volume reduction surgeiy published in the 3-month period. This information is available at www.cms.gov/MedicareApprovedFacilitie/LVRS/listasp#TopOfPage. For questions or additional information, contact Sarah Fulton, MRS (410-786-2749). Federal Register / Vol. 87, No. 27 / Wednesday, February 9, 2022 / Notices 17:29 Feb 08, 2022 Previous Re-certification Dates: 10/30/2008; 10/21/2010; 11/06/2012; 10/28/2014; 12/20/2016; 3/13/2019 The General Hospital Corporation 55 Fruit Street Roston, MA 02114 Provider Number 7470 VerDate Sep<11>2014 Facility lotter on DSK11XQN23PROD with NOTICES1 Federal Register / Vol. 87, No. 27 / Wednesday, February 9, 2022 / Notices [FR Doc. 2022–02677 Filed 2–8–22; 8:45 am] BILLING CODE 4120–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–1774–PN] Medicare Program; Announcement of Request for an Exception to the Prohibition on Expansion of Facility Capacity Under the Hospital Ownership and Rural Provider Exceptions to the Physician SelfReferral Prohibition AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. Notice with request for comment. ACTION: 17:29 Feb 08, 2022 Jkt 256001 owned hospital for an exception to the prohibition on expansion of facility capacity. This notice solicits comments on the request from individuals and entities in the community in which the hospital is located. Community input may inform our determination regarding whether the requesting hospital qualifies for an exception to the prohibition on expansion of facility capacity. Frm 00050 Fmt 4703 Sfmt 4703 09FEN1 7471 3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS–1774–PN, Mail Stop C4–26–05, 7500 Security Boulevard, Baltimore, MD 21244–1850. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: POH-ExceptionRequests@cms.hhs.gov. SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: https:// www.regulations.gov. Follow the search instructions on that website to view public comments. CMS will not post on Regulations.gov public comments that make threats to individuals or institutions or suggest that the individual will take actions to harm the individual. CMS continues to encourage individuals not to submit duplicative comments. We will post acceptable comments from multiple unique E:\FR\FM\09FEN1.SGM DATES: To be assured consideration, comments must be received at one of the addresses provided below, by March 11, 2022. ADDRESSES: In commenting, refer to file code CMS–1774–PN. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed): 1. Electronically. You may submit electronic comments on this regulation to https://www.regulations.gov. Follow the ‘‘Submit a comment’’ instructions. 2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS–1774–PN, P.O. Box 8010, Baltimore, MD 21244–1850. Please allow sufficient time for mailed comments to be received before the close of the comment period. PO 00000 SUMMARY: The Social Security Act prohibits a physician-owned hospital from expanding its facility capacity unless the Secretary of the Department of Health and Human Services grants the hospital’s request for an exception to that prohibition after considering input on the request from individuals and entities in the community where the hospital is located. The Centers for Medicare & Medicaid Services has received a request from a physician- VerDate Sep<11>2014 EN09FE22.011</GPH> Addendum XN: Medicare-Approved Bariatric Surgery Facilities (October through December 2021) Addendum XIV includes a listing of Medicare-approved facilities that meet minimum standards for facilities modeled in part on professional society statements on competency. All facilities must meet our standards in order to receive coverage for bariatric surgery procedures. On February 21, 2006, we issued our decision memorandum on bariatric surgery procedures. We determined that bariatric surgical procedures are reasonable and necessary for Medicare beneficiaries who have a body-mass index (BMl) greater than or equal to 35, have at least one co-morbidity related to obesity and have been previously unsuccessful with medical treatment for obesity. This decision also stipulated that covered bariatric surgery procedures are reasonable and necessary only when performed at facilities that are: (1) certified by the American College of Surgeons (ACS) as a Level 1 Bariatric Surgery Center (program standards and requirements in effect on February 15, 2006); or (2) certified by the American Society for Bariatric Surgery (ASBS) as a Bariatric Surgery Center of Excellence (ESCOE) (program standards and requirements in effect on February 15, 2006). There were no additions, deletions, or editorial changes to Medicare-approved facilities that meet CMS' minimum facility standards for bariatric surgery that have been certified by ACS and/or ASMBS in the 3-month period. This information is available at www.cms.gov/MedicareApprovedFacilitie/BSF/list.asp#TopOfPage. For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (October through December 2021) There were no FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials published in the 3-month period. This information is available on our website at www.cms.gov/MedicareApprovedFacilitie/PETDT/list.asp#TopOfPage. For questions or additional information, contact David Dolan, MBA (410786-3365).

Agencies

[Federal Register Volume 87, Number 27 (Wednesday, February 9, 2022)]
[Notices]
[Pages 7458-7471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02677]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9133-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--October through December 2021

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

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SUMMARY: This quarterly notice lists CMS manual instructions, 
substantive and interpretive regulations, and other Federal Register 
notices that were published from July through September 2021, relating 
to the Medicare and Medicaid programs and other programs administered 
by CMS.

FOR FURTHER INFORMATION CONTACT: It is possible that an interested 
party may need specific information and not be able to determine from 
the listed information whether the issuance or regulation would fulfill 
that need. Consequently, we are providing contact persons to answer 
general questions concerning each of the addenda published in this 
notice.

------------------------------------------------------------------------
             Addenda                    Contact            Phone No.
------------------------------------------------------------------------
I CMS Manual Instructions.......  Ismael Torres.....  (410) 786-1864
II Regulation Documents           Terri Plumb.......  (410) 786-4481
 Published in the Federal
 Register.
III CMS Rulings.................  Tiffany Lafferty..  (410)786-7548
IV Medicare National Coverage     Wanda Belle, MPA..  (410) 786-7491
 Determinations.
V FDA-Approved Category B IDEs..  John Manlove......  (410) 786-6877
VI Collections of Information...  William Parham....  (410) 786-4669
VII Medicare -Approved Carotid    Sarah Fulton, MHS.  (410) 786-2749
 Stent Facilities.
VIII American College of          Sarah Fulton, MHS.  (410) 786-2749
 Cardiology-National
 Cardiovascular Data Registry
 Sites.
IX Medicare's Active Coverage-    JoAnna Baldwin, MS  (410) 786-7205
 Related Guidance Documents.
X One-time Notices Regarding      JoAnna Baldwin, MS  (410) 786-7205
 National Coverage Provisions.
XI National Oncologic Positron    David Dolan, MBA..  (410) 786-3365
 Emission Tomography Registry
 Sites.
XII Medicare-Approved             David Dolan, MBA..  (410) 786-3365
 Ventricular Assist Device
 (Destination Therapy)
 Facilities.
XIII Medicare-Approved Lung       Sarah Fulton, MHS.  (410) 786-2749
 Volume Reduction Surgery
 Facilities.
XIV Medicare-Approved Bariatric   Sarah Fulton, MHS.  (410) 786-2749
 Surgery Facilities.
XV Fluorodeoxyglucose Positron    David Dolan, MBA..  (410) 786-3365
 Emission Tomography for
 Dementia Trials.
All Other Information...........  Annette Brewer....  (410) 786-6580
------------------------------------------------------------------------


SUPPLEMENTARY INFORMATION:

I. Background

    The Centers for Medicare & Medicaid Services (CMS) is responsible 
for administering the Medicare and Medicaid programs and coordination 
and oversight of private health insurance. Administration and oversight 
of these programs involves the following: (1) Furnishing information to 
Medicare and Medicaid beneficiaries, health care providers, and the 
public; and (2) maintaining effective communications with CMS regional 
offices, state governments, state Medicaid agencies, state survey 
agencies, various providers of health care, all Medicare contractors 
that process claims and pay bills, National Association of Insurance 
Commissioners (NAIC), health insurers, and other stakeholders. To 
implement the various statutes on which the programs are based, we 
issue regulations under the authority granted to the Secretary of the 
Department of Health and Human Services under sections 1102, 1871, 
1902, and related provisions of the Social Security Act (the Act) and 
Public Health Service Act. We also issue various manuals, memoranda, 
and statements necessary to administer and oversee the programs 
efficiently.
    Section 1871(c) of the Act requires that we publish a list of all 
Medicare manual instructions, interpretive rules, statements of policy, 
and guidelines of general applicability not issued as regulations at 
least every 3 months in the Federal Register.

II. Format for the Quarterly Issuance Notices

    This quarterly notice provides only the specific updates that have 
occurred in the 3-month period along with a hyperlink to the full 
listing that is available on the CMS website or the appropriate data 
registries that are used as our resources. This is the most current up-
to-date information and will be available earlier than we publish our 
quarterly notice. We believe the website list provides more timely 
access for beneficiaries, providers, and suppliers. We also believe the 
website offers a more convenient tool for the public to find the full 
list of qualified providers

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for these specific services and offers more flexibility and ``real 
time'' accessibility. In addition, many of the websites have listservs; 
that is, the public can subscribe and receive immediate notification of 
any updates to the website. These listservs avoid the need to check the 
website, as notification of updates is automatic and sent to the 
subscriber as they occur. If assessing a website proves to be 
difficult, the contact person listed can provide information.

III. How To Use the Notice

    This notice is organized into 15 addenda so that a reader may 
access the subjects published during the quarter covered by the notice 
to determine whether any are of particular interest. We expect this 
notice to be used in concert with previously published notices. Those 
unfamiliar with a description of our Medicare manuals should view the 
manuals at https://www.cms.gov/manuals.
    The Director of the Office of Strategic Operations and Regulatory 
Affairs of the Centers for Medicare & Medicaid Services (CMS), Kathleen 
Cantwell, having reviewed and approved this document, authorizes 
Trenesha Fultz-Mimms, who is the Federal Register Liaison, to 
electronically sign this document for purposes of publication in the 
Federal Register.

Trenesha Fultz-Mimms,
Federal Register Liaison, Department of Health and Human Services.
BILLING CODE 4120-01-C

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[FR Doc. 2022-02677 Filed 2-8-22; 8:45 am]
BILLING CODE 4120-01-C
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